Termination of pregnancy has been legalised in India during 1971,
mainly to prevent illegal abortions. Increased practice of
contraceptives has reduced the number of terminations to certain extent
in developed countries. But in developing countries like India large
number of medical termination of pregnancies have to be performed for
medical, social or for family welfare purpose. Many of the medical
termination seekers both primi and multigravida seek termination during
second trimester, when the surgical evacuation is risky where
complications like severe haemorrhage, cervical or uterine injuries and
severe infections may lead to grave immediate or late consequences.
Abortion is frequently performed in unsafe and undesirable conditions.
Illiteracy, ignorance combined with lack of adequate contraceptive
services has led to the problem of unwanted pregnancies very commonly
extending to second trimesters. With the advances in prenatal screening
more and more abnormal foetuses are being detected and hence the need
arises for safe methods of mid-trimester termination of pregnancy.

Surgical methods in second trimester are not without medical risks
and complications. So there is a need for alternate methods of
termination of pregnancy, preferably medical methods without any risks
or at least with minimal complications, easy and inexpensive. Use of
prostaglandin analogue E1 could be the right choice now.

Objective

The aim of this study is to evaluate the efficacy and safety of
vaginal misoprostol in second trimester abortion in both nulliparous and
multigravida with anomaly baby, dead foetus due to failure of
contraception or due to other medical causes.

MATERIALS AND METHODS

This is a descriptive hospital-based study design involving 75
patients attending the outpatient department for second trimester
pregnancy fulfilling the inclusion criteria.

Inclusion Criteria

1. Singleton pregnancy.

2. Nulliparous and multiparous.

3. Gestational age between 14 and 28 weeks.

4. Therapeutic termination.

a) Maternal-Severe postpartum haemorrhage. Antepartum eclampsia.

b) Foetal-IUD, Congenital anomalies.

c) E-Unmarried pregnancy, sterilisation failure.

d) Contraceptive failure.

Exclusion Criteria

1. Multiple gestations.

2. Abnormal vaginal bleeding.

3. Evidence of vaginal or cervical injuries.

4. H/O previous uterine surgeries.

5. H/O asthma, heart diseases, renal and hepatic dysfunctions.

Method

Informed written consent was obtained. General physical examination
to rule out systemic illnesses, local infections or any uterine adnexal
pathologies and to find out gestational age. Routine blood
investigations and urine analysis was done. Ultrasound examination for
gestational age, number of foetuses and their viability were documented.

Two tablets of misoprostol of 200 pgm were inserted intravaginally
into the posterior fornix and repeated after 6 hrs., if not aborted.
After the second dose, patients were observed for 24 hrs. as inpatients
in the hospital. Hourly monitoring was done for vital signs and
excessive vaginal bleeding. Progression of labour was assessed at the
time of repeat drug administration and also when bleeding was profuse or
uterine contractions were painful. Induction abortion interval was
noted. If abortion occurred within 24 hrs., the method was considered
successful.

Incomplete abortions were treated by oxytocin injections initially.
In case of failure to expel the placenta even with oxytocin or when the
women were bleeding profusely, suction or instrument evacuation of
retained products of conception was done under general anaesthesia.

Amount of post-abortion bleeding was assessed clinically. If
neither placenta nor foetus expelled even after 24 hrs., the induction
was judged to be a failure. A post-abortion antibiotic coverage was
given for 5 days with oral ampicillin. All failures were treated with
alternative methods like extraamniotic ethacridine lactate, oxytocin
infusion, cerviprime or hysterotomy as a last resort. Women requiring
sterilisation underwent bilateral tubal ligation in the immediate
postoperative period.

RESULTS

In our study with 75 patients with vaginal misoprostol for second
trimester of pregnancy, the safety and efficacy were definitely higher
than other methods of induction of abortion like Emcredil or higher
doses of oxytocin with very few side effects.

Total number of patients who developed side effects was 12 (16%).
Most common side effect was fever with temperature > 38 [degrees] C
(8%), vomiting (4%) and diarrhoea (4%). There was no incidence of any
adverse reactions to the drug. Induction abortion interval was also
superior to other methods; 26 patients expelled the foetus within 6-12
hrs. (39.4%) and the least was 8 patients within 18-24 hrs.; 12%
patients were considered as failure, as they did not respond to the
higher doses of misoprostol also.

DISCUSSION

It is difficult to terminate pregnancy in the second trimester with
reasonable safety as in first trimester. After the invention of the
prostaglandins, termination of pregnancy in second trimester is done
with ease with least side effects. The word prostaglandin was coined by
Von Euler (1985) believing it to be the active principle originating
from prostate gland. However, later it was found to be a family of
substances ubiquitously found in mammalian body. Corey et al (1969)
first synthesised prostaglandins. Prostaglandins are the family of
polyunsaturated 20-carbon compounds synthesised from arachidonic acid in
all living cells. Prostaglandin causes pronounce decrease in amount of
collagen, increasing collagenase activity and elastase activity.
Reduction in ground substance proteoglycan occurs as a result of local
or systemic administration of prostaglandins.

With oral administration half-life is less than 30 minutes and peak
level is at 15 minutes. After vaginal administration, there is a gradual
rise to a maximum level at 60 to 120 minutes, but at 240 minutes the
level is still at 60% peak level. The toxic dose of misoprostol in human
beings has not been determined. Cumulative daily dose of 1600 [micro]gms
has been tolerated.

In a study by KS Wong et al doses up to 4000 [micro]gms of
misoprostol have been tolerated. [1] Side effects are mainly
gastrointestinal side effects and fever.

For all the gestations of 11 to 20 weeks, dilatation and evacuation
is the method of choice in US according to Grimes (1977) and Peterson
(1983). [2] In India we prefer both medical methods and dilatation and
evacuation.

Jain JK et al reported in a study, induction abortion interval rate
within 6 hrs. was 14%; 12 hrs. was 39.3% and within 24 hrs. was 15.7%.
[3] He also concluded that the live foetus had high failure rate of
abortion and longer time to abort than dead foetus. But in our study,
the complete abortion rates of live and dead foetus were 83.9% and 89.7%
respectively. Failure rate for live and dead foetus were 12.5% and 10.5%
respectively. According to Chi-square test, X2= 0.059 suggesting
difference was not statistically significant.

In spite of various methods of contraception available, patients go
for illegal abortions and second trimester terminations. This according
to David T Baird, may be related to inadequate organisation of abortion
services and lack of widespread availability of these drugs
(Misoprostol) to the woman throughout the country. [4]

Srisomboon J, in his study (1977), evaluated the efficacy and side
effects of vaginal misoprostol in termination of second trimester
pregnancy in women who were recruited to receive 400 pgms of Misoprostol
every 6 hrs. [5] The rate of complete abortion defined as passage of
foetus and placenta without operative assistance was 80%. Side effects
were fever (8%), nausea and vomiting (6%) and diarrhoea (2%). Thus, in
his conclusion misoprostol is effective, cheap, safe and relatively
convenient method for second trimester termination of pregnancy. This is
comparable to our study where complete abortion rate is 85.4% and
failure rate is 12%.

Pongpisuttinum S, in his study described about the complications,
compared the success rate in induction abortion interval between the
live and dead foetus in second trimester termination with vaginal
misoprostol. [6] In his study, the rate of successful abortion within 24
hrs. in live foetus and dead foetus were 54.7% and 83.3% respectively.
The success rate within 24 hrs. in live group was significantly lower
than those of dead foetus group. No serious complications occurred in
terms of haemorrhage, febrile morbidity, diarrhoea, nausea and vomiting.
In our study, complete abortion rate for live and dead foetus was 83.9%
and 89.7% respectively and failure rate was 12.5% and 10.5%. According
to Chi-square test [X.sup.2] = 0.059, suggesting difference was
statistically not significant.

Even though oral administration is appealing for several reasons
like convenient and lack of invasiveness, vaginal route seems to be more
advantageous (Dickinson JE, 2014). [7]

Another study by Elami-Suzin compares the efficacy of mifepristone
plus misoprostol and mifepristone plus oxytocin; also confirms vaginal
misoprostol has least side effects and convenient. [8]

A study by MacIsaac revealed the absorption kinetics of misoprostol
with a dose of 400 [micro]gms compared between oral administration and
vaginal treatment. [9] This study showed systemic bioavailability of
vaginally administered misoprostol was three times greater than oral
route.

Lesser the dosage used, side effects were less. Herabutya in his
study compared the doses of 200 [micro]gms and 400 [micro]gms over a
period of 6 hrs. and concluded that 400 [micro]gms dose was more
effective as an abortifacient with fewer side effects. [10] High doses
were associated with adverse effects like fever, nausea, vomiting and
diarrhoea.

Though studies done by Webster D had used 200 [micro]gms mifeprin
tablets prior to misoprostol for second trimester termination, our study
obviates the need for prior use of Tab. Mifepristone in second trimester
termination of pregnancy. [11]

CONCLUSION

The present study further documents the positive experience on the
safety and efficacy of vaginal misoprostol tablets in inducing second
trimester abortions. It is cost-effective, easy to administer and has
very less side effects. The failure rate and incomplete abortion is very
less. Nevertheless, as shown in this study, problem still remains in a
minority of non-responding women and it is a responsibility of any
clinician to be able to offer alternative methods to complete the
abortion in safe manner.

Study Design

A descriptive hospital-based study design was used for this study.
Purposive sampling was done for this study.

Sample Size

Sample size was determined by referring the book of WHO publication
1991 titles sample size determination in health studies, written by
Lwanga SK and Lemeshow S; anticipating population proportion of second
trimester pregnancies attending OG OPD using the formula

Data was entered in Microsoft XL and analysis was done using Epi
Info software version 3.5.4. Proportions were calculated for various
variables and Chi-square test and student's test were done for
statistical significance of the outcome.